Table 2.
Adverse Events in the Overall Population of 184 Patients.*
| Adverse Events | Any Grade | Grade 3 | Grade 4 |
|---|---|---|---|
| number of patients (percent) | |||
| Any adverse event† | 183 (99.5) | 89 (48.4) | 7 (3.8) |
| Nausea | 143 (77.7) | 14 (7.6) | 0 |
| Fatigue | 91 (49.5) | 11 (6.0) | 0 |
| Alopecia | 89 (48.4) | 1 (0.5) | 0 |
| Vomiting | 84 (45.7) | 8 (4.3) | 0 |
| Constipation | 66 (35.9) | 1 (0.5) | 0 |
| Decreased neutrophil count‡ | 64 (34.8) | 36 (19.6) | 2 (1.1) |
| Decreased appetite | 57 (31.0) | 3 (16) | 0 |
| Anemia§ | 55 (29.9) | 15 (8.2) | 1 (0.5) |
| Diarrhea | 54 (29.3) | 5 (2.7) | 0 |
| Decreased white-cell count¶ | 39 (21.2) | 11 (6.0) | 1 (0.5) |
| Decreased platelet count|| | 39 (21.2) | 7 (3.8) | 1 (0.5) |
| Headache | 36 (19.6) | 0 | 0 |
| Cough | 35 (19.0) | 0 | 0 |
| Abdominal pain** | 31 (16.8) | 2 (1.1) | 0 |
| Decreased lymphocyte count†† | 26 (14.1) | 11 (6.0) | 1 (0.5) |
| Adverse events of special interest | |||
| Interstitial lung diseas‡‡ | 25 (13.6) | 1 (0.5) | 0 |
| Prolonged QT interval | 9 (4.9) | 2 (1.1) | 0 |
| Infusion-related reaction | 4 (2.2) | 0 | 0 |
| Decreased left ventricular ejection fraction§§ | 3 (16) | 1 (0.5)¶¶ | 0 |
Listed are adverse events that were reported in more than 15% of the patients. The safety analysis set included the 184 patients who were enrolled in part 1 or part 2 of the study and who received at least one dose of trastuzumab deruxtecan. Details regarding adverse events that were reported in more than 10% of the patients are provided in Table S5.
Adverse events that are listed in this category were reported by the investigator. They include adverse events of grade 3 or higher that were reported in at least 6% of the patients.
This category includes the preferred terms neutrophil count decreased and neutropenia.
This category includes the preferred terms hematocrit decreased, hemoglobin decreased, red-cell count decreased, and anemia.
This category includes the preferred terms white-cell count decreased and leukopenia.
This category includes the preferred terms platelet count decreased and thrombocytopenia.
This category includes the preferred terms abdominal discomfort, abdominal pain, abdominal pain lower, and abdominal pain upper.
This category includes the preferred terms lymphocyte count decreased and lymphopenia.
The presence of interstitial lung disease was determined by an independent adjudication committee, since the condition has been associated with trastuzumab deruxtecan. Four patients who had grade 5 events are included in the category of any grade.
The left ventricular ejection fraction was measured on echocardiography or multigated acquisition scans every four treatment cycles.
In this patient, the left ventricular ejection fraction was more than 55% during treatment.